Simultanious multi-parameter physiological monitoring device with local and remote analytical capability

ABSTRACT

Handheld medical diagnostic instrument that provides high time-resolution pulse waveforms associated with multiple parameters including blood pressure measurements, blood oxygen saturation levels, electrocardiograph (ECG) measurements, and temperature measurements. The device stores and analyzes the pulse waveforms simultaneously obtained from all tests, and thereby allows an unusually detailed view into the functioning of the user&#39;s cardiovascular heart-lung system. The device is designed for use by unskilled or semi-skilled users, thus enabling sophisticated cardiovascular measurements to be obtained in a home environment. Data from the device can be analyzed onboard, with local computerized devices, and with remote server based systems. The remote server may be configured to analyze this data according to various algorithms chosen by the physician to be most appropriate to that patient&#39;s particular medical condition (e.g. COPD patient algorithms). The server may be further configured to automatically provide alerts and drug recommendations.

CROSS REFERENCE TO RELATED APPLICATIONS

This invention claims the priority benefit of U.S. provisional patentapplication 61/767,839 “SIMULTANEOUS MULTI-PARAMETER PHYSIOLOGICALMONITORING DEVICE WITH DUAL LOCAL AND REMOTE ANALYTICAL CAPABILITY”,first inventor Xinde Li, filed Feb. 22, 2013; the complete contents ofwhich are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention is in the field of medical devices to monitor bloodpressure, blood oxygen levels, and obtain electrocardiograms. Inparticular the invention is in the field of handheld medical devicedesigned for easy use by unskilled or semi-skilled patients andhealthcare professionals.

2. Description of the Related Art

The human cardiovascular system is a complex system involving the heart,lungs, arteries, veins and other body components. The human heart itselfcan be viewed as an electrically triggered four-chamber pump. The rightatrium receives deoxygenated blood (generally more blue in color) fromthe veins, passes the blood to the right ventricle, where the blood ispumped to the lungs. At the lungs, the blood becomes oxygenated (andalso changes to a red color depending upon how much oxygen has beenabsorbed).

The left atrium receives oxygenated blood from the lungs, and passesthis oxygenated blood to the left ventricle, which in turn sendsoxygenated blood to the body via various arteries. During eachheartbeat, usually in response to various electrical pulses (which canbe monitored using electrodes and electrocardiogram type methods)various pulsatile sounds are generated (called Korotkoff sounds whenused in a cuff-type blood pressure monitoring context), and variouspulsatile changes in blood pressure also occur. For example, when theleft ventricle is pushing oxygenated blood to the body, blood pressureis higher (systolic blood pressure), and in between heartbeats, when theheart is momentarily resting, the blood pressure is lower (diastolicblood pressure), and these pressure measurements vary according to thepatient's pulse rate (typically between about 30 to 200 times perminute).

Various medical abnormalities can alter this process. For example, somemedical conditions may cause the heart to beat irregularly (cardiacarrhythmia), and such cardiac arrhythmias are often of high medicalconcern. Blood pressure may be too high or too low. Due to eithercardiac problems, lung problems, or a combination of the two, blood maynot be sufficiently oxygenated as it passes through the lungs. Indeed insome diseases, such as chronic obstructive pulmonary disease (COPD), allaspects of the cardiovascular system may be gravely damaged.

Not surprisingly, given how fundamental a well performing cardiovascularsystem is to human health, various methods of monitoring differentaspects of the human cardiovascular system have been developed.

Thus if a heart is receiving abnormal electrical signals, which can bediagnosed by electrodes and electrocardiographic (ECG) methods, theheart muscle may contract abnormally. This abnormal heart musclecontraction may in turn generate an abnormal pulse with characteristicsounds and characteristic changes in blood pressure. These pulse signalsmay be monitored by traditional sphygmomanometer type blood pressuremonitors, which apply pressure to a portion of the body, and monitor theKorotkoff sounds with a stethoscope as a function of the amount ofapplied pressure. The pulse signals may also be monitored by morerecently developed oscillometric methods, where oscillating pressuremeasurements at various cuff pressure levels can be automaticallyanalyzed according to various algorithms, and pulse results produced.The variation in blood color (light absorption spectra) as a function ofblood oxygen levels (saturation) can also be monitored by various typesof pulse oximeter measurements.

Previous work in these fields includes Uemura, U.S. Pat. Nos. 4,262,674and 4,484,584; Taniguchi, U.S. Pat. No. 4,566,464, Shimazu, U.S. Pat.No. 5,680,867, Swearington, U.S. Pat. No. 4,263,918, Amano U.S. Pat. No.6,095,984, Forstner U.S. Pat. No. 6,485,429, and Muradina, US patentpublications 20080077435 and 20120330675; the complete contents of theseapplications are incorporated herein by reference.

The role of telemedicine in assisting care for COPD was recentlyreviewed in 2012 article by McLean et. al., (“Telehealthcare for chronicobstructive pulmonary disease (Review)”, The Cochrane Library 2012,issue 8, published by John Wiley & Sons, Ltd).

Methods to derive respiratory rate from pulse oximeter data wasdiscussed by Addison et. al., (“Developing an algorithm for pulseoximetry derived respiratory rate (RRoxi): a healthy volunteer study, J.Clin. Monit. Comput (2012) 26: 45-51), and by Leonard et. al., “Standardpulse oximeters can be used to monitor respiratory rate”, Emerg Med J2003, 524-525.

Oscillometric methods to measure systolic and diastolic blood pressurewere discussed in Babbs, (“Oscillometric measurement of systolic anddiastolic blood pressures validated in a physiologic mathematicalmodel”, Biomedical Engineering Online 2012 11;56.)

BRIEF SUMMARY OF THE INVENTION

For critically ill patients in intensive care settings, who aretypically under the direct supervision of one or more physicians, it isnow standard practice to monitor a number of different cardiovascularparameters simultaneously. However in settings outside of hospitalintensive care units, such as home settings, such multi-parametermeasurements are rarely, if ever, done.

Here, because some embodiments of the invention may be designed for homeuse by unskilled patient/users, the terms “patient” and “user” willoften be used interchangeably.

The invention is based, in part, on the insight that although wrist andarm based blood pressure monitors are simple to use, and thus are oftenpreferred by patients in a home monitoring situation, merely monitoringonly blood pressure during a routine blood pressure monitoring sessionrepresents a wasted opportunity. To more fully utilize this time windowof patient interaction with a medical diagnostic device, a more capabledevice that is also capable of recording additional relevant patientphysiological information, such as patient electrocardiogram (ECG) andblood oxygen levels, as well as other parameters such as temperature andbreathing rate would be also desirable. It would further be desirable toprovide an ability to extensively analyze the data remotely, as well asto easily relay the data to healthcare providers, caregivers, and otherdecision makers.

Blood oxygen levels can be produced by, for example, using various typesof clip on finger pulse oximeters. These clip on finger pulse oximetersoperate by shining light of various wavelengths through the patient'sfingernail or other part of the patient's finger, often at wavelengthsaround 660 nm or infra-red wavelengths around 905-940 nm, where thecolor of blood hemoglobin is highly variable according to the degree ofoxygenation of the blood, and other reference wavelengths, such as 590,and/or 805 nm, where the color of blood hemoglobin remains more constantregardless of degree of oxygenation. After passing through at least partof the finger or fingernail, the light is then detected with aphotodetector, analyzed using a computer processor, and blood oxygenlevel computed.

By contrast, electrocardiogram (ECG) measurements are usually difficultand cumbersome to obtain, because most medical grade ECG measurementsrequire that multiple electrode leads (e.g. 12 leads) be placed (usuallytaped) around various areas of the patient's body. In addition toproviding additional medically useful information, multiple leads canalso reduce noise and improve the quality of the signal.

The invention is based in part, on the insight that there may beadvantages to abandoning the medical prejudice in favor of high numbersof electrode leads for ECG applications. If ECG methods using a smallernumber of leads are used, such as one reference lead attached to thepatient's finger, and another lead attached to the patients oppositehand, then the same clip-on finger pulse oximeter used to obtain a bloodoxygen measurement could also be used to hold a clip on lead for asimple ECG measurement as well.

The invention is further based on the insight that the box or chassisused to hold the working components (e.g. air pump, microprocessor,battery, display) of a portable handheld wrist or arm blood pressuresensor can also be used to provide the reference electrode(s) for an ECGmeasuring device.

The invention is further based on the insight that it would be useful tocombine, in one basic handheld instrument (or device), the functions ofa wrist or arm mounted blood pressure monitor (with inflation cuff);with a clip on finger blood pulse oximeter that also includes a firstECG electrode lead and optional temperature sensor. The invention isfurther based on the insight that it would be useful to position anotherECG electrode lead on the surface of the handheld device. Such a devicewould enable the patient or user to hold the device chassis in one hand,thus establishing an ECG electrode connection. The wrist or arm bloodpressure monitoring cuff can be mounted on the wrist of the user's otherhand. The clip-on combination blood oximeter/electrode (with optionaltemperature sensor) can be placed over the user's finger. The system canbe further configured with a microprocessor that directs the device tosense the status of the various sensors multiple times per second whilepressure is automatically applied to the inflation cuff, and store theresults in memory.

Such a device would provide a wealth of data, such as synchronized bloodpressure cuff obtained pulse waveforms, oximeter obtained pulsewaveforms, and ECG waveforms while pressure was progressively appliedand then released on the patient's wrist. This in turn would generate alarge amount of physiologically relevant patient data that could then beused to monitor for the presence or progression of various diseases, inparticular various cardiovascular diseases and lung diseases, such asCOPD.

The invention is also based, in part, on the insight that although smallstandalone diagnostic instruments are often most convenient to use forrapid point of care acquisition of information, often the onboardanalytical and data display capabilities of such devices aresub-optimal. Thus providing standalone capable medical diagnosticdevices with the capability of interfacing with other computer systemswith additional analytical and display software capability, eitherthrough local and more capable computerized devices (e.g. local personalcomputers, tablet computers, and the like) or remotely (e.g. throughvarious server systems) would be particularly desirable formulti-parameter monitoring devices, such as the invention's combineddevice.

The remote server approach has some additional advantages as well. Inaddition to providing additional computing capability, a remote servercan provide a means for providing a higher level of quality control (QA)in a home-monitoring situation. Traditionally, Q/A has been difficultfor home-based monitoring situations. However remote servers can use theperson's historic data, population data from other users, and knowledgeof the characteristics of that device and the population of similar typedevices for purposes of improved raw-data validation, as well asproviding improved user guidance as to best modes of using the device,and best times for data collection.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the multi-parameter monitoring device operating in computeraccessory mode, where the device may be controlled by anothercomputerized device through a data connection such as a USB orBluetooth™ connection, and in some embodiments also obtain power throughthe other computerized device. Both a prototype design, as well as amore refined version of the device, are shown.

FIG. 2 shows the multi-parameter monitoring device operating in astandalone mode, here drawing power from its internal battery.

FIG. 3 shows an example of the multi-parameter monitoring device runninga blood pressure measurement, ECG measurement, and blood oximetermeasurement at same time.

FIG. 4A shows the interior of the combination finger mounted oximeterand ECG electrode device, taken from two slightly different angles,showing the springs, finger baffle, oximeter LEDs and photodetectors,and the ECG finger electrode.

FIG. 4B shows how the user's finger interacts with the interior of thecombination finger mounted oximeter and ECG electrode device. Here, tobetter see the oximeter optical sensors and the ECG finger electrode,the two sides of the clamshell type finger probe are shown in an openconfiguration, but in use the two sides will be closed, thus bringingthe oximeter sensor and the ECG electrode in contact with the user'sfinger.

FIG. 5 shows the multi-parameter monitoring device working as a simpleblood pressure monitor.

FIG. 6 shows the front panel of the multi-parameter monitoring device.

FIG. 7A shows a simplified electrical schematic of the multi-parametermonitoring device.

FIG. 7B shows a portion of the interior of the device, showing thedevice's pneumatic pump, valve, and tube connection to a microphone orpressure sensor, internal batteries, cuff port, port for the combinationoximeter/ECG, USB port. A portion of the device's optional externalmemory SD card slot is also visible. In some embodiments, the interiorof the device may also contain an interface for an optional temperaturesensor. The temperature sensor or sensors may be mounted either on thedevice itself (often underneath the device's ECG electrode) or on theclamshell type finger probe.

FIG. 8 shows how the external software portion of the invention, hererunning on an external computerized device, can receive themulti-parameter monitoring device's data, and display multiple channelsof information on a graphical user interface (GUI). There real-timewaveform displays of the pressure pulse, blood pressure, oximeter O₂levels, and ECG waveforms are being displayed.

FIG. 9A shows how the external software portion of the invention, hererunning on an external computerized device can receive themulti-parameter monitoring device's data, and display on the externalcomputerized device's screen, blood pressure measurements withadditional ECG, finger pulse, and blood pressure. Additionally variousmulti-parameter monitoring devices' testing settings, patientinformation, and data files can also be set or accessed through thisGUI.

FIG. 9B shows how the user may zoom in to display more details of thevarious physiological waveforms previously shown in FIG. 9A.

FIG. 10 shows how the external software portion of the invention, hererunning on an external computerized device, can also be used formanaging the multi-parameter monitoring device's various files of testrecords

FIG. 11 shows how the external software portion of the invention, hererunning on an external computerized device, can also be used to managethe multi-parameter monitoring device's configuration settings and otherfunctions, such as the multi-parameter monitoring device's real-timeclock/calendar.

FIG. 12 shows an alternative software portion of the invention, hereoptimized to run on a tablet type external computerized device, usingsignals further processed by a remote server. This display shows theoutput of various physiological parameters determined either directlyfrom the device, or computed indirectly using various algorithms. Theresults include systolic blood pressure (SYS), diastolic blood pressure(DIA), pulse rate average (PRA), pulse rate variability (PRV), heartarrhythmia (TAS), blood oxygen saturation (SpO2), breathing rate average(BRA), and body temperature (TEMP).

FIG. 13 shows an example of the device sending data via Bluetooth™ to alocal Bluetooth equipped smartphone, and the smartphone in turntransmits (relays) this data to a remote internet server for furtheranalysis. The patient or physician can then download this serveranalyzed data to their local computerized devices (here a tablet device)for subsequent evaluation, and/or configure the server to automaticallyreact in certain situations.

DETAILED DESCRIPTION OF THE INVENTION

In one embodiment, the invention may be a portable handheld device andmethod for simultaneously monitoring pulse waveforms indicative of bloodpressure, blood oxygen levels, and electrocardiogram signals. Thisdevice will generally comprise a handheld base unit controlled by atleast one microprocessor or microcontroller, suitable control software(often stored in flash memory), additional memory (e.g. RAM, additionalFlash memory, which may also be used to store data accumulated by thedevice), a display such as an LCD display, and various user controlinputs such as various buttons, switches and the like.

The microprocessor or microcontroller will generally comprise, or atleast be connected to, a plurality of ports to drive various externaldevices to be discussed, as well as various inputs to either directlydigitize various input analog signals, or else accept analog inputs indigital form via various external A/D converters.

In some embodiments the display may be a touch sensitive display, inwhich case at least some of the various user control inputs may beimplemented via the touch sensitive display.

Although in some embodiments, the device may be configured for use byunskilled users such as in a home setting, the device will alsofrequently be configured for professional healthcare worker use as well.

The handheld base unit will generally comprise one or more air pumps andvalves for driving a pneumatic blood pressure monitoring cuff (e.g. asphygmomanometer), as well at least one detector, such as a microphoneor pressure sensor to monitor pulse input (e.g. pulse sounds or pulsepressure differences) from the blood pressure monitoring cuff (usuallycarried by hollow tubing). This pneumatic blood pressure monitoring cuff(e.g. cuff, external cuff) will connect to the handheld base unit viaintermediate tubing and via a hole or port in the handheld base unit(external cuff port).

The handheld base unit will often further comprise at least one firstECG electrode(s) mounted on the external chassis of the handheld baseunit (302). This first ECG electrode will generally be placed in an areaof the external chassis that would be a natural location for the patient(i.e. person being monitored) to hold the unit by one hand. Thus thisfirst ECG electrode is intended to directly touch the patient's handwhile the patient is holding the handheld base unit. In someembodiments, a temperature sensor, configured to measure the temperatureof the user's hand, may also be positioned on or below this first ECGelectrode.

The interior of the handheld base unit will also contain electricalcircuitry for an ECG amplifier, as well as an electrical ECG/oximeterport to receive input from a second ECG electrode mounted on theinterior of an external finger mounted combination pulse-oximeter/ECGelectrode device. This will be discussed in more detail shortly. Thisexternal finger-mounted combination pulse-oximeter/ECG electrode devicecan be used by the system, in conjunction with the first ECG electrodeon the exterior of the device housing, to obtain electrocardiogram pulsewave information.

Note that in a preferred embodiment, the finger mountedpulse-oximeter/ECG electrode will be mounted on a digit of the patient(i.e. finger, toe) that is different from the hand that the patient isusing to hold the external chassis of the handheld base unit. Generally,the electrical path should at least in part cross the patient's heart.

The interior of the handheld base unit will also contain electricalcircuitry to drive a plurality of finger pulse oximeter light sources ata plurality of wavelengths, and to receive photodetector signals from,the oximeter portion of the combination external finger mountedpulse-oximeter/ECG electrode device. The interior of the handheld baseunit will optionally also contain electrical circuitry to read thestatus of at least one temperature sensor mounted either on the externalfinger-mounted pulse-oximeter/ECG electrode device, or on the handheldbase unit.

The device software may be configured so that when a blood pressuremonitoring cuff is temporarily or permanently plugged into the device'sexternal cuff port (and then placed around the limb of a patient, suchas around the wrist of the patient's arm), and the device's externalfinger mounted combination pulse-oximeter/ECG electrode device is placedaround the digit of the patient (ideally a finger or thumb of the handopposite to the hand of the patient that is holding the chassis andfirst electrode of the handheld device), the device will then apply (viathe microprocessor or microcontroller at least one air pump and valve)varying amounts of air pressure to the cuff, usually by way of a hollowtube connecting the cuff to the device base unit.

The device's blood pressure microphone or other sensor (e.g. a pressuresensor) will typically either listen to patient pulse sounds, or morecommonly (using oscillometric methods) measure pressure differencestraveling over the hollow tube. This sensor will thus obtain pulse waveinformation as a function of applied cuff air pressure. Alternativelythe device may contain a microphone (or other sensor such as a pressuresensor) mounted as part of the pneumatic blood pressure cuff, and obtaindata by this method.

Generally the pulse sounds/pressure fluctuations vary as a function ofapplied cuff pressure, and patient blood pressure. When patients withhigher blood pressure are tested, the pulse sounds or pulse pressurefluctuations to persist at higher cuff pressures. By contrast forpatients with lower blood pressure, the pulse sounds or pulse pressurefluctuations will be more diminished at higher cuff pressures. Thismethod can not only be used to obtain blood pressure (i.e. systolic,diastolic readings), but additionally, the shape of the waveforms canalso be monitored, typically at least several times a second, to obtainfurther information pertaining to the presence of various cardiacarrhythmias and other medical disorders as well.

As previously discussed, blood pressure information may be obtained byeither automatic (e.g. microprocessor performed) analysis of theKorotkoff sounds or by more modern oscillometric methods. In a preferredmode, oscillometric methods will be used. These methods may operateaccording to the algorithms of Babbs, (“Oscillometric measurement ofsystolic and diastolic blood pressures validated in a physiologicmathematical model”, Biomedical Engineering Online 2012 11;56.), or byalternative algorithms.

Examples of how such waveforms (often obtained using oscillometricmethods) may be used to diagnose cardiac disease and arrhythmias arediscussed in more detail in the Nov. 9, 2011 Biosign publication“Arrhythmias The UFIT® acquired pulse waveform is a simple andinformative mode of screening for arrhythmias, as well as a longitudinaltool for monitoring changes in the rhythm of the pulse”, and the Nov.25, 2011 Biosign “ANSI/AAMI SP10 Report The UFIT® measurement of bloodpressure meets all performance requirements of ANSI/AAMI SP10:2002 as anautomated sphygmomanometer.”, the contents of which are provided asreferences and the contents of which are also incorporated herein byreference.

The device may also be configured (e.g. via software andmicroprocessor/microcontroller control) to drive the externalcombination finger pulse-oximeter/ECG electrode device at a plurality ofwavelengths, and obtain blood hemoglobin absorbance information as afunction of wavelength and as a function of pulse wave. This methodworks because hemoglobin is known to change its relative absorbance atcertain wavelengths very strongly as a function of degree ofoxygenation, but at other wavelengths the absorbance of hemoglobinvaries little or at all depending upon degree of oxygenation. At thesame time, depending upon the pulse cycle, at some pulse stages such asduring the contraction stage, the capillaries of the skin and tissuesare filled with red-cell containing blood (where the hemoglobin isstored), while at other stages of the pulse cycle, such as during therelaxation stage, there is relatively little red blood cells andhemoglobin present, thus allowing background absorbance due to otherbody tissues to be subtracted from the overall signal. The net result isthat by suitable analysis, both another type of pulse wave reading isobtained, and additionally the degree of oxygenation of the blood canalso be determined.

This degree of oxygenation differs slightly according to if the patienthas just inhaled or just exhaled, and thus breathing rate informationmay also be extracted by automated analysis pulse oximeter data as well.

An additional advantage of combining finger based blood oximeter datawith a wrist or arm mounted blood pressure cuff type blood pressuremonitor is that the combination of the two different modes of collectingdata can potentially provide more accurate systolic and diastolic bloodpressure measurements. This is because during the time when the bloodpressure cuff is inflated to the maximum extent to measure the systolicphase of the pulse (maximum contraction), the pulse pressure wavedetected by the blood pressure monitor is at a maximum, and at the sametime the smallest quantity of blood, and likely more deoxygenated bloodis received at the user's finger. This shows up as local pulse minimumsin the hemoglobin and oxyhemoglobin oximeter blood absorption channels.

By contrast, during the time when the blood pressure cuff is deflatingin order to measure the resting phase of the heartbeat (diastolicphase), the pressure wave detected by the blood pressure monitor is at aminimum, while both a larger amount of blood, and also generally moreoxygenated blood, is received at the user's finger. This shows up asgreater signals in the hemoglobin and oxyhemoglobin oximeter bloodabsorption channels.

Thus when the pressure in the cuff is greater than the patent's systolicblood pressure, the blood flow to the patient's palm is cut-off and,thus the finger mounted pulse-oximeter will not register or detect anypulses. However when the pressure in the cuff falls below the patient'ssystolic blood pressure, but is still greater than the patient'sdiastolic blood pressure, there will be intermittent blood flow to thepatient's fingers, producing an abnormal set of pulse waveforms. Thisintermittent blood flow can be detected by the finger mountedpulse-oximeter. In general, the pulse detected by the finger mountedpulse-oximeter will start to more fully resemble a normal pulse when thepressure in the cuff falls below the patient's diastolic pressure.

Thus, regardless of if the blood pressure cuff is operating by theoscillometric blood pressure method by detecting pressure sensorchanges, or if the blood pressure cuff is operating by analysis ofKorotkoff sounds using a microphone type sensor, any errors in the bloodpressure' cuff assessment of systolic and diastolic blood pressure can,at least to some extent be either detected, or preferably evencorrected, by use of blood oximeter data.

Thus in some embodiments, either the device's software and processor (orthe remote server processor and software) may be further configured touse the blood hemoglobin absorbance information as a function ofwavelength and as a function of pulse wave to improve the accuracy ofblood pressure monitoring information obtained from the blood pressuremonitoring cuff.

According to the invention, the device is also configured to monitorelectrical signals from a first ECG electrode mounted on the externalchassis of the handheld base unit, and a second ECG electrode mounted onthe interior of the device's external, finger-mounted, combination pulseoximeter and ECG electrode.

This thus allows the device to obtain electrocardiogram electrical pulsewave information as well, usually during the same time that the cuff isoperating producing its type of audio pulse wave data, and the oximeteris obtaining blood oxygen levels and optical pulse wave data. The netresult is a “three dimensional” electrical/audio/optical analysis of thesame pulse waves. That is, same heart beats can be analyzed from a bloodpressure standpoint, a blood oxygen standpoint, and an ECG electricalactivity standpoint. This technique thus provides a unique perspectiveon patient cardiovascular information. Critically, due to theportability and ease of use of the device, this data can be obtained ina much broader range of settings (e.g. clinic, home, travel) settingsthan otherwise was previously feasible. This facilitates both higherfrequency monitoring, as well a better monitoring during times that thepatient may be experiencing some distress at home.

In a preferred embodiment, the device software is configured to directthe device's microprocessor or microcontroller to store (in either localor remote memory), either the direct sensor readings, or alternativelyor additionally variously mathematically processed versions thesereadings. Thus on a simultaneous or near-simultaneous basis, bloodpressure monitoring pulse wave information (data), data from theexternal, finger mounted, combination pulse-oximeter/ECG electrode bloodoxygen levels (e.g. device blood hemoglobin absorbance information as afunction of wavelength pulse wave information), and variouselectrocardiogram pulse wave information useful for detecting cardiacarrhythmias and other problems can be obtained.

Although, in many embodiments, the device may be configured to analyzethe data internally using its onboard microprocessor/controller oronboard software, in a preferred embodiment, the device may also beconfigured provide these various types of data, along with engineeringdata such as device air pressure information, light source drivingtiming data, amplifier settings, what part of the body the varioussensors are connected to, and the like, to an external computerizeddevice or remote server (often with more sophisticated data analysiscapability) via a wired, wireless, or optical communications port.

This external computerized device or remote server, which often may havemore data analysis and/or display capability than the device itself, mayin turn be configured to analyze this data, generate medically usefulgraphs of this data, and also report on medically useful parameters suchas various mathematically computed blood pressure, blood oxygen level,and ECG results.

As will be discussed, the remote server approach is also particularlyuseful because it can give the physician more options to customize theautomated data analysis and medical recommendation process to the needsof individual patients. The remote server approach can also beparticularly useful for home monitoring applications, because the remoteserver can also provide improved quality assurance (Q/A) and control.This is particularly important for home monitoring situations, where thechances of error may be higher.

The external computerized device may be a laptop computer connected tothe invention using a wired USB (Universal Serial Bus) connection, as isshown in FIG. 1. However in a preferred mode, the external computerizeddevice may be a smaller handheld device, such as a smartphone or tabletcomputer, connecting to the invention using a wireless Bluetooth™connection. This smaller handheld device may in turn connect to remoteservers using WiFi or direct cellular (e.g. 3G, 4G) type wirelessconnections. In some embodiments, some data analysis may be donedirectly on the local external computerized device, while more extensivedata analysis, which may be done by various physician selectedalgorithms, may be done on the remote servers, and then relayed to thephysician or other healthcare provider.

EXAMPLES

One embodiment of the device is exemplified by the UFIT-max system,presently in development. The UFIT-max is a portable vital signmonitoring device that integrates automatic blood pressure monitor,single lead ECG and pulse oximeter functions, and optional bodytemperature sensor into a personal digital accessory (PDA) (e.g.handheld) sized box.

The device can work either in external computer interface mode (e.g. PCmode) as shown in FIG. 1 or in a standalone mode running on batteries asshown in FIGS. 2 and 3.

FIG. 1 shows the multi-parameter monitoring device (100) operating incomputer accessory mode, where the device may be controlled by anothercomputerized device (102) through a data connection such as a USB orBluetooth™ connection (here via a USB cable, and in FIG. 13 via awireless Bluetooth™ connection), and in some embodiments also obtainpower through the other computerized device (102). The device's bloodpressure monitoring cuff (104) and finger mounted combinationoximeter/ECG electrode (106) are also shown. In this embodiment, thedevice (100) may be powered though a USB cable connection (108) andexchange data with the other computerized device (102).

FIG. 1 shows two versions of the device: (100) shows the prototypedevice, while (100 a) shows a possible industrial design for thecommercial version of the device, along with the cuff (104 a) andcombination oximeter/ECG electrode (106 a) for this more commercializeddevice.

FIG. 2 shows a close up of the multi-parameter monitoring device (100),pneumatic blood pressure cuff, first externally mounted ECG electrode(200) and finger mounted combination oximeter/ECG electrode (106). Herethe device is not connected to an external computer, but rather isoperating in a standalone mode drawing power from its internal battery(see FIG. 7B).

FIG. 3 shows an example of the multi-parameter monitoring device (100)running a blood pressure measurement, ECG measurement, and bloodoximeter measurement at same time in standalone mode.

In a preferred embodiment, the invention will be designed to be easy touse. For example, one first ECG electrode (200) may be integrated andonto the device box (e.g. external chassis) (100), and another othersecond ECG electrode may be integrated inside the finger mountedoximeter probe (106). Temperature sensors configured to monitor bodytemperature can optionally be mounted under either ECG electrode, orelsewhere as desired.

Here, for example, the finger mounted combination oximeter/ECG probe maybe mounted on a digit (e.g. finger) of the patients (or users) left hand(300), while the patient (user) holds or touch the ECG pad with theright hand (302), thus allowing an ECG electrical connection that passesat least in part through the user's heart to be established.

The blood pressure, ECG and oximeter signals can be collectedsimultaneously. Each signal channel can work independently or incooperation with other channels. The device software can recognize theconfiguration and process the data accordingly. Thus once the device isset up, minimal or no further operator intervention is needed.

FIG. 4A shows the interior of the combination finger mounted oximeterand ECG electrode probe (106), taken from two slightly different angles,showing the probe's two clamshell sides (400), (402), springs (404),finger baffle (406), oximeter LEDs (408) and photodetectors (410), andthe ECG finger electrode (412) (second ECG electrode).

FIG. 4B shows how the user's finger (300) interacts with the interior ofthe finger mounted combination oximeter and ECG electrode device (106).Here, to better see the oximeter optical sensors and the ECG fingerelectrode, the two sides of the clamshell type finger probe are shown inan open configuration, but in use the two sides will be closed, thusbringing the oximeter sensor (410) and the second ECG electrode (412) incontact with the user's finger (300). A temperature sensor mayoptionally be mounted near 408 and/or 410 (not shown) or elsewhere.

FIG. 5 shows that in some modes, the multi-parameter monitoring devicecan also operate as a simple, stand alone, blood pressure monitor.

FIG. 6 shows a close-up of the front panel of the multi-parametermonitoring device (100), showing the device display (600), controlbuttons (602), (604), power button (606) and ports (608), (610). Thedevice is also showing some patient readings directly on its display(600).

The device is designed to be simple to operate, and thus compatible foruse by unskilled users in a home environment. For example, in someembodiments as shown in FIG. 6, using only the power button (606) andtwo control buttons (602), (604); the user can easily start/stop tests,as well as review test records that have been saved in the device'sbuilt-in flash memory. This particular embodiment system has a built inreal-time clock/calendar, and generally all test records aretime-stamped. This onboard Calendar/Timer may further have power backup,such as a built-in super capacitor, to allow time-keeping to continueeven when the device is unpowered.

When run in standalone mode under battery operation, this particularembodiment (i.e. this particular device) uses a 160×100 greyscalegraphic LCD (600) to display the various test operating instructions,modes and results. For example, display (600) can show, ECG, fingerpulse and cuff pressure pulse waveform data, along with date/timedisplay, temperature display, blood pressure measurement display, heartrate, heart rate variation, systolic and diastolic pressure, and thelike. The LCD display can also be used to review test record files,which contain the saved test records which cover blood pressure,temperature heart rate. As previously discussed, all test records may betime-stamped. Users can thus browse the test record based on testingdate and time.

In a preferred or at least alternative embodiment, however, the devicemay be configured to communicate via a short range wireless connection,such as a Bluetooth® connection, to a local computerized device such asa smartphone or tablet computer. This local computerized device willtypically be equipped with a high resolution color touchscreen, whichwill facilitate data display and analysis. This preferred or alternative“Bluetooth to smartphone” embodiment in action is shown in more detailin FIG. 13.

The start and stop buttons (602) and (604) can be used to start or stopthe various measurements. In some embodiments, these start/stop buttonsare multi-functional. When not in testing mode these two buttons canalso be used for browsing the unit's on-chip test record file.Alternative control methods, such as using a touch sensitive display(600), can also be used.

An overview of the device's various major electrical components is shownin FIG. 7A.

FIG. 7B shows a portion of the interior of the device, showing thedevice's pneumatic pump (700), valve (702), and hollow tube connectionto a microphone sensor or pressure sensor (704), internal batteries(706), cuff port (610), port for the finger mounted combinationoximeter/ECG probe, and mini-USB port (708). A portion of the device'soptional external memory SD card slot (710) is also visible.

This particular device is capable of running under internal power using3 AAA batteries (706), but can also draw power (5V /500 mA) from its USBinterface if the device is connected to a suitable USB power source.

As previously discussed, the device may be designed with variousflexible communication ports and interfaces. In one embodiment, thedevice can communicate with an external computerized device (e.g. a PC)(102) through the device's Universal Serial Bus (USB) port (708) orwireless Bluetooth™ transceiver. This particular device, as shown inFIGS. 1-7 features a USB interface (708) capable of full speed operationup to 12M Byes/Sec, a Bluetooth 2.0 transceiver, and an SD memory cardinterface (710). This SD memory card interface allows large amount ofdata (e.g. 2 Gigabytes) to be logged and transferred to an externalcomputerized device at any time, and thus serves as a useful supplementto the unit's standard internal flash memory.

Built-in Storage: In this particular example, the unit's on-chip filemanagement system allows the user to save up to 1000 test records, whichas described elsewhere generally cover blood pressure, temperature,heart rate, and heart rate variation. Each test record may be identifiedby a time stamp. The user can review these past test results directly onthe device in standalone mode according to the date and time the testingwas done. The data files are non-volatile, and the data can be retainedeven when device is powered off.

In addition to the various data acquisition channels previouslydiscussed, the device may optionally also monitor the patient'stemperature or ambient temperature and other parameters.

As previously discussed, the various data provided by this embodiment ofthe invention can also be analyzed by external software running onvarious external computerized devices, here exemplified by Windows basedPersonal Computers (PCs), (see FIG. 1, 102) but which can be any type ofexternal device (e.g. smartphones, tablet computers, desktop computers,and the like), including remote servers.

In the FIG. 1 (102) example, and in the screenshots shown in FIGS. 8-11,this external analysis software is Microsoft Windows based software,capable of running under one or more processors (e.g. microprocessors)under various 32 and 64 bit windows operating systems including WindowsXP, Windows Vista, Windows 7, 64 bit systems: Windows XP x64Bit, WindowsVista x64Bit, and Windows 7 x64 Bit, Windows 8, and the like. In otherembodiments, the external device analysis software may run under otheroperating systems such as iOS, Android, Linux, Unix, Windows and thelike.

In some embodiments, internal or external device control and managementsoftware may include a data acquisition control graphical user interface(GUI). This GUI may do various functions such as real time waveformdisplay for ECG, finger pulse determination, cuff pressure control andcuff pressure pulse determination.

Other functions may include real time temperature display, and/orprovide a GUI for blood pressure measurement, waveform display for theECG results, finger pulse results, cuff pressure results, as well ascuff pressure pulse during the deflation time of a blood pressurereading.

Various start/pause/stop buttons to may be used to control the cuffinflation and deflation process. Other GUI controls, such as variousZoom in/Zoom Out /Cursor buttons can be used to allow the user to easilyview and analyze the various waveforms. Thus, for example, the user maypick one or more waveform peaks, calculate various waveform peakparameters, such as distance between peaks, and so on.

In some embodiments, an analyze button will allow the user to startvarious software analysis functions which can estimate heart rate, heartrate variation, systolic pressure, diastolic pressure and the like fromeither real-time data or from previously saved data.

Other GUI functions, such as patient information, can allow the user toinput various patient related information into the system, such aspatient age, gender, height, weight and so on. Various Save/Read filebuttons can be used to allow the user to save and retrieve various typesof test raw data and other test related information.

Alternatively in some embodiments, the device may be connected to alocal Bluetooth™ computerized device such as a smartphone (See FIG. 13,1300), in which case the invention may be at least to some extentremotely controlled using the smartphone or other local computerizeddevice.

In some embodiments, the device software may also provide a GUI forvarious types of device built-in storage management. These functions caninclude functions such as download test records from the device, savetest records to an external device file such as a PC file. Otherfunctions may include buttons to allow the user to save device testrecord data to various file formats such as spreadsheet (e.g. MicrosoftExcel) files. A read test records from PC file button/function can allowthe user to retrieve various saved test records and view each testrecord as desired.

The external device software can also include a GUI for deviceconfiguration. This can be used, for example, to allow the user to reador set the device's clock/calendar timer, and/or allow the user tosynchronize the device's time with the external computerized devices(e.g. PC) time. Other functions include allowing the user to choosevarious communication channel output modes (e.g. USB or Bluetooth) andallow a user check on the status of the device's built-in disk (e.g.solid state memory) capacity.

FIG. 8 shows how the external software portion of the invention, hererunning on an external computerized device (e.g. laptop, smartphone,tablet computer, and the like) can receive the multi-parametermonitoring device's data, and display multiple channels of informationon a graphical user interface (GUI). There real-time waveform displaysof the pressure pulse, blood pressure, oximeter O₂ levels, and ECGwaveforms are being displayed.

FIG. 9A shows how the external software portion of the invention, hererunning on an external computerized device can receive themulti-parameter monitoring device's data, and display on the externalcomputerized device's screen, blood pressure measurements withadditional ECG, finger pulse, and blood pressure. Additionally variousmulti-parameter monitoring devices' testing settings, patientinformation, and data files can also be set or accessed through thisGUI.

FIG. 9B shows how the user may zoom in to display more details of thevarious physiological waveforms previously shown in FIG. 9A.

FIG. 10 shows how the external software portion of the invention, hererunning on an external computerized device, can also be used formanaging the multi-parameter monitoring device's various files of testrecords

FIG. 11 shows how the external software portion of the invention, hererunning on an external computerized device, can also be used to managethe multi-parameter monitoring device's configuration settings and otherfunctions, such as the multi-parameter monitoring device's real-timeclock/calendar.

FIG. 12 shows an alternative software portion of the invention, hereoptimized to run on a tablet type external computerized device, usingsignals further processed by a remote server, showing output of variousphysiological parameters including systolic blood pressure (SYS),diastolic blood pressure (DIA), pulse rate average (PRA), pulse ratevariability (PRV), heart arrhythmia (TAS), blood oxygen saturation(SpO2), breathing rate average (BRA), and body temperature (TEMP).

FIG. 13 shows an example of the diagnostic device (100) sending data viaa wireless Bluetooth® connection to a local (to the patient) Bluetoothequipped smartphone (1300). This smartphone in turn transmits data overthe internet (1302) to a remote server (1304) and server memory (1306)for further analysis. At the server, the physician or other healthcareprofessional can analyze the data using either standardized algorithms,or alternatively using physician selected algorithms that are, at leastsome extent, customized to that particular patient, or customizedaccording to physician preference. The patient or physician can thendownload this server analyzed data to their local computerized devices(here a tablet device 1308) for subsequent evaluation.

The server can comprise at least one processor (often chosen from thepopular x86, ARM, or MIPS family of processors), Internet networkinterface, memory, an operating system (e.g. Linux, Unix, Windows), andvarious ancillary programs such as web server software (e.g. Apache),database management programs (e.g. MySQL, MariaDB, MongoDB, etc.),various scripting languages (e.g. Perl, Python, PHP and the like) aswell as the various specific web pages, scripts, and other programs usedto implement the functionality disclosed herein.

Although software and algorithms running on one or more processorsaboard the local device (1300), the physician's remote device (1308) oreven on the diagnostic device (100) itself can in principle perform manydifferent types of analysis, there are a number of advantages toallowing the remote server (1304) and memory (1306) to take on at leastsome of the burden of data storage and data analysis. These are:

1: Due to the fact that the server memory (1306) has a potentiallyunlimited capacity, as well as due to the fact that it will befrequently updated with the results from a large number of differentpatients, the server algorithms can make use of various features, suchas pattern recognition, that would not be as feasible on other devices.

2: Due to the fact that the server algorithms can be under physiciancontrol, this enables (with proper safeguards) the physician tocustomize the algorithms to the preferences of that particular physicianand patient. For example, a physician may choose to go to a moresensitive setting, and accept the risk of more false alarms, from aknown critically ill COPD patient. By contrast, the same physician,knowing that another patient is relatively healthy, may choose to selecta less sensitive setting that generates fewer false alarms.Additionally, some physicians may wish to suppress alerts from all butthe most urgent situations, while other physicians may wish to generallyget more frequent alerts from their respective patients.

3: Due to the fact that the server can also have access to populationdata from a large number of patients, as well as population data from alarge number of similarly designed devices, the server approach also canprovide superior quality assurance (Q/A) and control. This isparticularly useful in home monitoring situations, where Q/A concernsare often higher than in professional use situations. For example, theserver software may be configured to perform additional checks toconfirm that the data being collected is reasonable, as well asadditional checks to detect potential errors during data acquisition.The server software may also be configured, as needed, to request theuser to repeat collections as needed, set or change data collectionintervals, recommend proper data collection settings, and the like.

Additionally, putting the algorithms on a server enables the physicianto use more advanced analysis algorithms that may, for example, havebeen validated by various academic publication, and/or even officiallyrecommended by the medical association for that particular disease, butwhich may not have yet been approved by the Food and Drug Administrationfor routine use in embedded medical devices. This can, depending uponphysician judgment, actually improve patient safety and care because FDAreview of new software algorithms intended to be embedded permanentlyinto medical devices can be very slow and expensive. Indeed it can be soslow and expensive that many promising and clinically useful algorithmsmay never obtain official FDA approval for embedding into medicaldevices for general purpose use.

Although this patent application is not intended to provide legal orregulatory advice, historically the FDA has generally been morepermissive about allowing physicians to use their minds andsupplementary physician calculating tools, such as spreadsheets. Thepresent invention's “Cloud Diagnostics™ ” approach allows physicians toextend their minds and calculating tools to select various algorithmsthat may be most appropriate to their particular patients, without theenormous burden of having to prove that the algorithm works for allpatents at all times. So long as the physician or the medical society iswilling to assume risk and liability for their use, then a wider varietyof useful algorithms may be used then would otherwise be possible. Thiscan result in better patient care and superior outcomes.

As an example of this, consider the case of an American physician whorealizes that his patients are being inadequately served by systems thatare presently being marketed. Suppose that in response to a peerreviewed articles such as Jensen et. al., “Clinical impact of hometelemonitoring on patients with chronic obstructive pulmonary disease.,Telemed J E Health, 2012 Nov. 18(9) 674-8, a well-respected COPD medicalsociety has recently recommended this approach as the proper standard ofcare for this disease. Suppose also that the physician is also unwillingto wait an unknown amount of time, likely many years if ever, until FDAapproved devices implementing this recommended method are on the market,because most probably many of the physician's patients will die in themeantime.

To avoid these preventable deaths, the physician instead can use theinvention to set up a semi-automated system that recommends changes inantibiotics and steroid administration (or other drugs) in response topatient uploaded measurements of systolic and diastolic blood pressure,pulse rate, and blood oxygen saturation. Here the physician may simplyupload or otherwise select appropriate server analysis parameters, andhave the system automatically inform the physician and patient when drugdosage changes may be advisable.

The patient can thus receive a nearly instant alert when medicationshould be adjusted. As a safety precaution, the server software can beset up to allow the physician to review and override these servergenerated recommendations if, in the physician's judgment, they areinappropriate. The remote server system can thus be set up so that thephysician's professional judgment can remains in the loop at all times,but the system can provide extremely rapid (i.e. responses on the orderof seconds) response times. Reliability can be improved as well, becausethe sever can respond 24 hours a day, seven days a week, and thuscontinue to apply the physician's best judgment even during periods whenthe physician may be asleep, distracted, or otherwise unavailable.

Trademarks: Bluetooth® is both a trademark of the Bluetooth specialinterest group, as well as a common term to refer to the IEEE 802.15 setof standards for wireless connectivity. Cloud Diagnostics™ is atrademark of Biosign Technologies, Inc.

1. A portable handheld device for simultaneously monitoring pulsewaveforms indicative of blood pressure, blood oxygen levels, andelectrocardiogram signals, said device comprising: a handheld base unitcomprising a microprocessor or microcontroller, software, memory,display, and user control inputs; said handheld base unit furthercomprising an air pump and valve for driving a blood pressure monitoringcuff, at least one detector to monitor pulse input from said bloodpressure monitoring cuff, and an external cuff port to accommodate thetubing for said blood pressure monitoring cuff; said handheld base unitfurther comprising an external first ECG electrode configured to touchthe patient's hand while the patient is holding said handheld base unit,ECG amplifier, and an electrical ECG/oximeter port to receive input froma second ECG electrode mounted on the interior of an external fingerpulse oximeter/ECG electrode device, thereby also obtainingelectrocardiogram pulse wave information; said electrical ECG/oximeterport further configured to drive a plurality of finger pulse oximeterlight sources at a plurality of wavelengths, and to receivephotodetector signals from said finger pulse oximeter/ECG electrodedevice; wherein when a blood pressure monitoring cuff is plugged intosaid external cuff port and placed around the limb of a patient, andsaid external finger pulse oximeter/ECG electrode device is furtherplaced around a digit of said patient, said device is configured toapply varying amounts of air pressure to said cuff and obtain pulse waveinformation from said cuff, said device is also configured drive saidexternal finger pulse oximeter/ECG electrode device at a plurality ofwavelengths, and obtain blood hemoglobin absorbance information as afunction of wavelength and as a function of pulse wave, and said deviceis configured to monitor electrical signals from said first ECGelectrode and second ECG electrodes, thereby deriving electrocardiogrampulse wave information; wherein said device software is configured todirect said microprocessor or microcontroller to store in either localor remote memory, either direct or mathematically processed versions ofsaid blood pressure monitoring pulse wave information, said externalfinger pulse oximeter/ECG electrode device blood hemoglobin absorbanceinformation as a function of wavelength pulse wave information, and saidelectrocardiogram pulse wave information.
 2. The device of claim 1,wherein said device software and processor is further configured to usesaid blood hemoglobin absorbance information as a function of wavelengthand as a function of pulse wave to improve the accuracy of bloodpressure monitoring information obtained from said blood pressuremonitoring cuff.
 3. The device of claim 1, wherein said device isconfigured to transmit any or all of said blood pressure monitoringpulse wave information data, said external finger pulse oximeter/ECGelectrode device blood hemoglobin absorbance information data, and saidelectrocardiogram pulse wave information, along with device air pressureinformation data and light source driving information data, to anexternal computerized device or remote server via a wired, wireless, oroptical communications port.
 4. The device of claim 3, wherein saidexternal computerized device or remote server is configured to analyzesaid data, generate medically useful graphs of said data, and report onmathematically computed blood pressure, blood oxygen level, and ECGresults.
 5. The device of claim 3, wherein said external computerizeddevice is a remote server, and wherein said remote server is furtherconfigured to analyze said data according to patient specific algorithmscustomized for the health status of an individual patient using saiddevice; and wherein said remote server is further configured toautomatically generate at least one of medical alerts or drug dosageadvisory messages according to patient specific algorithms customizedfor the health status of said individual patient; or wherein said remoteserver is further configured to automatically generate quality assurancealerts.
 6. The device of claim 1, wherein at least one of said pluralityof light sources is set at a wavelength where the absorbance of bloodhemoglobin changes substantially as a function of the degree ofoxygenation of said blood hemoglobin, and at least one of said pluralityof light sources is set at a wavelength where the absorbance of bloodhemoglobin changes minimally as a function of the degree of oxygenationof said blood hemoglobin; and where said air pump and valves areconfigured to deliver air pressure to said cuff at varying pressurelevels set to allow said device to obtain medically useful bloodpressure readings.
 7. The device of claim 1, further comprising a bloodpressure monitoring cuff configured to detachably plug into saidexternal cuff port; and a combination external pulse oximeter/ECGelectrode device configured to detachably plug into said electricalECG/oximeter port.
 8. The device of claim 1, further comprising a bloodpressure monitoring cuff configured to permanently plug into saidexternal cuff port; and a combination external pulse oximeter/ECGelectrode device configured to permanently plug into said electricalECG/oximeter port.
 9. The device of claim 1, wherein said software isconfigured to compute at least blood pressure results, blood oxygenlevel results, and graphically display electrocardiogram signal resultsas a function of time, and display said results on said display withoutthe need of interfacing with an external computerized device or remoteserver.
 10. The device of claim 1, wherein either said external fingerpulse oximeter/ECG electrode device or said handheld base unit furthercomprises a temperature sensor configured to monitor the bodytemperature of said patient.
 11. A method of simultaneously monitoringpulse waveforms indicative of blood pressure, blood oxygen levels, andelectrocardiogram signals, said method comprising: providing a portablehandheld base unit comprising a microprocessor or microcontroller,software, memory, display, and user control inputs; said handheld baseunit further comprising an air pump and valve for driving a bloodpressure monitoring cuff, at least one detector to monitor pulse inputfrom said blood pressure monitoring cuff, and an external cuff port toaccommodate the tubing for said blood pressure monitoring cuff; saidhandheld base unit further comprising an external first ECG electrodeconfigured to touch the patient's hand while the patient is holding saidhandheld base unit, ECG amplifier, and an electrical ECG/oximeter portto receive input from a second ECG electrode mounted on the interior ofan external finger pulse oximeter/ECG electrode device, thereby alsoobtaining electrocardiogram pulse wave information; said electricalECG/oximeter port further configured to drive a plurality of fingerpulse oximeter light sources at a plurality of wavelengths, and toreceive photodetector signals from said finger pulse oximeter/ECGelectrode device; said blood pressure monitoring cuff being plugged intosaid external cuff port; said external finger pulse oximeter/ECGelectrode device being plugged into said electrical ECG/oximeter port;placing said blood pressure monitoring cuff around the limb of apatient; placing said external finger pulse oximeter/ECG electrodedevice around the digit of said patient; instructing said patient tohold said base unit so that said first ECG electrode makes electricalcontact with the hand of said patient holding said base unit, while saidsecond ECG electrode makes electrical contact with a digit on either adifferent hand or a toe of said patient; using said air pump and valveto apply varying amounts of air pressure to said cuff and obtainingpulse wave information data from said cuff as a function of airpressure; driving said external finger pulse oximeter/ECG electrodedevice at a plurality of wavelengths, and using said photodetector toobtain blood hemoglobin absorbance information data as a function ofwavelength and as a function of pulse wave; monitoring electricalsignals from said first ECG electrode and second ECG electrodes, therebyderiving electrocardiogram pulse wave information data; using saidmicroprocessor or microcontroller to store either direct ormathematically processed versions of said blood pressure monitoringpulse wave information, said external finger pulse oximeter/ECGelectrode device blood hemoglobin absorbance information as a functionof wavelength pulse wave information, and said electrocardiogram pulsewave information in either local memory or remote memory.
 12. The methodof claim 11, further using said microprocessor or microcontroller totransmit any or all of said blood pressure monitoring pulse waveinformation data, said external finger pulse oximeter/ECG electrodedevice blood hemoglobin absorbance information data, and saidelectrocardiogram pulse wave information, along with device air pressureinformation data and light source driving information data, to anexternal computerized device or remote server via a wired, wireless, oroptical communications port.
 13. The method of claim 12, wherein saidexternal computerized device or remote server comprises at least oneprocessor, further using said external computerized device or remoteserver's at least one processor to analyze said data, generate medicallyuseful graphs of said data, and report on mathematically computed bloodpressure, blood oxygen level, and ECG results.
 14. The method of claim12, wherein said external computerized device is a remote servercomprising at least one server processor; using said at least one serverprocessor on said remote server to analyze said data according topatient specific algorithms customized for the health status of anindividual patient using said device; and further using said at leastone server processor on said remote server to automatically generatemedial alerts or drug dosage advisory messages according to patientspecific algorithms customized for the health status of said individualpatient.
 15. The method of claim 14, further using pulse oximeteralgorithms to indirectly determine the breathing rate of said patientfrom said finger pulse oximeter data, or to improve the accuracy ofblood pressure monitoring information obtained from said blood pressuremonitoring cuff.
 16. The method of claim 14, further using COPD drugdose algorithms and said data to recommend or change dose levels of atleast one drug used to treat COPD.
 17. The method of claim 14, furtherusing oscillometric analysis algorithms and said data to determine atleast one of the systolic blood pressure, diastolic blood pressure,average pulse rate, variation in pulse rate, and pulse arrhythmia. 18.The method of claim 14, further uploading patient specific medicalanalysis parameters and patient specific drug dosage algorithmparameters to said server, and using at least one server processor, saiddata, said patient specific medial analysis parameters, and said patientspecific drug dosage algorithm parameters to recommend or change doselevels of at least one drug used to treat said patient.
 19. The methodof claim 14, further providing a plurality of medical analysisalgorithms and parameters and patient specific drug dosage algorithmsand parameters on said server, and providing a menu allowing anauthorized physician to select which of said plurality of medicalanalysis algorithms and/or patient specific drug dosage algorithms andparameters are to be used to analyze data from specific patients. 20.The method of claim 14, further transmitting duplicate copies of saidautomatically generated medial alerts or drug dosage advisory messagesto both said patient and said physician.